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NDA

BETAMETHASONE DIPROPIONATE | N208079 | PRIMUS PHARMACEUTICALS INC

1 strength7 unique patents0 unique exclusivities

Patent Timeline

7 unique patents by expiration date

Active (7)Today

2027

2028

2029

2030

Today

Aug. 31, 2030

Aug. 31, 2030

Aug. 31, 2030

Aug. 31, 2030

Aug. 31, 2030

Aug. 31, 2030

Aug. 31, 2030

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Promius Pharma LLC v. Perrigo UK FINCO Limited Partnership et al 2:2018cv00219	E.D. Tex.	2018-05-22	Terminated 2018-12-03	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

140 trials from ClinicalTrials.gov — 1 recruiting, 93 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Treatment Results for Patients With Central Centrifugal Cicatricial Alopecia (CCCA): a Multicenter Prospective Study NCT04207931	Phase 4	Recruiting	Wake Forest University Health Sciences	250	2018-04-30 → 2027-03
Effect of Betamethasone Gel and Lidocaine Jelly on Sore Throat, Cough and Hoarseness of NCT02114021	Phase 3	Completed	Tehran University of Medical Sciences	99	2012-03 → 2013-03
A Randomised Trial of a Moisturising Cream in Preventing Recurrence of Hand Eczema NCT00576550	Phase 4	Completed	ACO Hud Nordic AB	53	2007-10 → 2008-05
Antenatal Corticoid Therapy for Late Preterm Babies NCT00675246	N/A	Completed	Instituto Materno Infantil Prof. Fernando Figueira	320	2008-05 → 2010-05
Trial to Assess the Potency of SOR007 Ointment in a Psoriasis Plaque Test NCT03004339	Phase 1	Completed	DFB Soria, LLC	13	2016-08 → 2017-02-13
A Trial That Compound Clobetasol Propionate Ointment Treats Patients With Mild to Moderate Psoriasis Vulgaris.NCT02733874	Phase 4	Completed	First Hospital of China Medical University	240	2015-04
Comparison of Topical Latanoprost vs Topical Corticosteroid in Treatment of Localized Alopecia Areata NCT02350023	Phase 4	Completed	Post Graduate Institute of Medical Education and Research, Chandigarh	50	2014-09 → 2015-03
A Clinical Trial to Compare Topical Agents in Adults With Mild to Moderate Atopic Dermatitis (AD)NCT02376049	Phase 1	Completed	LEO Pharma	30	2015-02 → 2015-07
India Dexamethasone and Betamethasone NCT03668860	Phase 1	Completed	Children's Hospital Medical Center, Cincinnati	48	2018-09-20 → 2019-12-31
Prophylaxis of Postoperative Nausea and Vomiting After Cardiac Surgery NCT02744495	Phase 3	Completed	Hôpital Privé de Parly II - Le Chesnay	502	2016-02 → 2016-12

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain9 active DMFs6 inactive

9 active API suppliers hold Drug Master Files for this ingredient.

TAPI NL BVBETAMETHASONE DIPROPIONATE

DMF 41481981

TARO PHARMACEUTICAL INDUSTRIES LTDBETAMETHASONE DIPROPIONATE USP, MICRONIZED

DMF 146511999

CURIA SPAIN SAUBETAMETHASONE DIPROPIONATE

DMF 170462003

HALCYON LABS PRIVATE LTDBETAMETHASONE DIPROPIONATE USP

DMF 205822007

FARMABIOS SPABETAMETHASONE DIPROPIONATE MICRONIZED

DMF 231182009

SYMBIOTICA SPECIALITY INGREDIENTS SDN BHDBETAMETHASONE DIPROPIONATE

DMF 244862010

SYMBIOTEC PHARMALAB PRIVATE LTDBETAMETHASONE DIPROPIONATE

DMF 257982012

TIANJIN TIANYAO PHARMACEUTICALS CO LTDBETAMETHASONE DIPROPIONATE USP

DMF 352322020

HENAN LIHUA PHARMACEUTICAL CO LTDBETAMETHASONE DIPROPIONATE

DMF 358532021

GLAXOCHEM LTDInactiveBETAMETHASONE DIPROPIONATE PRODUCED IN THE MONTROSE, SCOTLAND PLANT

DMF 51571983

COMPANIA ESPANOLA DE SINTESIS QUIMICA SAInactiveBETAMETHASONE DIPROPIONATE

DMF 67261986

PHARMACIA AND UPJOHN SUB PFIZER INCInactiveBETAMETHASONE DIPROPIONATE

DMF 70951987

QUATRUMInactiveBETAMETHASONE DIPROPIONATE

DMF 71251987

HOECHST MARION ROUSSEL SAInactiveBETAMETHASONE DIPROPIONATE

DMF 73891988

MAHIMA LIFE SCIENCES PRIVATE LTDInactiveBETAMETHASONE DIPROPIONATE USP

DMF 226492008

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
May 26, 2026	SUPPL -4	View Letter (PDF)
Mar 25, 2020	SUPPL -2	View Letter (PDF)
Dec 7, 2018	SUPPL -1	View Letter (PDF)
Feb 9, 2016	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 0.05% BASE/SPRAY

RLD

7 patents0 exclusivities▴

SPRAY;TOPICAL | Approved: Feb 5, 2016

Patents (7) · 7 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Delist
9364485	Aug 31, 2030	—	—	Yes	—
9433630	Aug 31, 2030	—	—	Yes	—
9439911	Aug 31, 2030	—	—	Yes	—
9655907	Aug 31, 2030	—	—	Yes	—
9775851	Aug 31, 2030	—	—	Yes	—
9877974	Aug 31, 2030	—	—	Yes	—
10179137	Aug 31, 2030	—	—	Yes	—